Docetaxel monotherapy: Docetaxel 75 mg/m2 solution administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.

DOXIL+Docetaxel

DOXIL and docetaxel combination: DOXIL 30 mg/m2 solution administered by intravenous infusion, followed by docetaxel 60 mg/m2 administration by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.

Participant Flow: Overall Study

Docetaxel

DOXIL+Docetaxel

STARTED

373

378

COMPLETED

4 [1]

5 [1]

NOT COMPLETED

369

373

Progressive Disease

220

189

Physician Decision

61

58

Withdrawal by Subject

38

46

Adverse Event

29

48

2cycles therapy beyond Complete response

9

16

Death

9

7

Lost to Follow-up

1

3

Not Specified

2

6

[1]

Indicates number of participants on study treatment at time of the primary objective

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

No text entered.

Reporting Groups

Description

Docetaxel

Docetaxel monotherapy: Docetaxel 75 mg/m2 solution administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.

DOXIL+Docetaxel

DOXIL and docetaxel combination: DOXIL 30 mg/m2 solution administered by intravenous infusion, followed by docetaxel 60 mg/m2 administration by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.

Time to Progression [ Time Frame: From date of randomization until date of disease progression or death, whichever occurred first, until approximately 485 events of disease progression or death were observed, as assessed approximately 15 months after the last patient was enrolled ]

Time interval in months between the date of randomization and the date of disease progression or death due to progression, whichever occurred first.

Time Frame

From date of randomization until date of disease progression or death, whichever occurred first, until approximately 485 events of disease progression or death were observed, as assessed approximately 15 months after the last patient was enrolled

Safety Issue

No

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

Intent to Treat: For patients who were progression free at the time of data cutoff, data were censored for time to progression at the time of their last tumor assessment.

Reporting Groups

Description

Docetaxel

Docetaxel monotherapy: Docetaxel 75 mg/m2 solution administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.

DOXIL+Docetaxel

DOXIL and docetaxel combination: DOXIL 30 mg/m2 solution administered by intravenous infusion, followed by docetaxel 60 mg/m2 administration by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.

Measured Values

Docetaxel

DOXIL+Docetaxel

Participants Analyzed [Units: Participants]

373

378

Time to Progression [Units: Months]Median (95% Confidence Interval)

7.0
(5.9 to 7.7)

9.8
(8.1 to 10.5)

Statistical Analysis 1 for Time to Progression

Groups [1]

All groups

Method [2]

Log Rank

P Value [3]

<0.0001

Hazard Ratio (HR) [4]

0.65

95% Confidence Interval

0.55 to 0.77

[1]

Additional details about the analysis, such as null hypothesis and power calculation:

Null hypothersis - no difference in Time to Progression (TTP) between the two treatment groups.

Designed to detect an improvement in median TTP from 6 months to 7.8 months with 80% power, assuming exponential survival distribution.

[2]

Other relevant method information, such as adjustments or degrees of freedom:

No text entered.

[3]

Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:

No text entered.

[4]

Other relevant estimation information:

No text entered.

2. Secondary:

Overall Survival [ Time Frame: From the date of randomization until the participant's death from any cause, as assessed until approximately 485 death events were observed which is assessed approximately 25 months after the last patient was enrolled ]